[Federal Register Volume 77, Number 191 (Tuesday, October 2, 2012)]
[Notices]
[Pages 60125-60126]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-24326]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-1006]


Generic Drug Facilities, Sites and Organizations

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of Requirement.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is notifying generic 
drug facilities, and certain sites and organizations identified in a 
generic drug submission, that they must provide identification 
information to FDA. This information is required to be submitted to the 
FDA annually under the Generic Drug User Fee Act Amendments of 2012 
(GDUFA) included in the Food and Drug Administration Safety and 
Innovation Act (FDASIA). This notice is intended to help organizations 
ascertain if they need to self-identify with the FDA, determine what 
information they are required to submit, and familiarize themselves 
with the means and format for submitting the required information.

DATES: For fiscal year 2013, identification information must be 
submitted by December 3, 2012. For each subsequent fiscal year, 
identification information must be submitted, updated, or reconfirmed 
on or before June 1 of the preceding fiscal year.

ADDRESSES: Electronic tools for submitting the required information may 
be found at the following Web sites:
     eSubmitter tool: http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm108165.htm.
     Structured Product Labeling (SPL) Xforms: http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm189651.htm.
    Step-by-step instructions for electronically creating, validating, 
and submitting self-identification information are available at 
www.fda.gov/gdufa. Technical specifications for self-identification are 
also available at www.fda.gov/gdufa. Once finalized, the file should be 
transmitted to FDA through the Electronic Submissions Gateway (ESG), 
FDA's electronic information portal. Information on the ESG is 
available at http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm.

FOR FURTHER INFORMATION CONTACT:  Jaewon Hong, Center for Drug 
Evaluation and Research (HFD-300), Food and Drug Administration, 10903 
New Hampshire Ave., Silver Spring, MD 20993-0002, 1-866-405-5367 or 
301-796-6707.

SUPPLEMENTARY INFORMATION: On July 9, 2012, GDUFA (FDASIA, Title III) 
(Pub. L. 112-144, Title III) was signed into law by the President. 
GDUFA requires that generic drug facilities, and certain sites and 
organizations identified in a generic drug submission, provide 
identification information annually to FDA. This notice specifies who 
is required to self-identify, the type of information to be submitted, 
the means and format for submission of this information, and the 
penalty for failing to comply. Additional information is contained in 
the draft guidance for industry entitled ``Self-Identification of 
Generic Drug Facilities, Sites and Organizations'' available at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. This self-identification information will assist in 
constructing an accurate inventory of facilities, sites and 
organizations involved in the manufacture of generic drugs. Among other 
things, the identification information may be used by FDA for purposes 
including setting fee amounts and targeting inspections.

I. Who is required to self-identify?

    The following types of generic industry facilities, sites, and 
organizations are required to be identified to FDA:
    1. Facilities identified, or intended to be identified in at least 
one generic drug submission that is pending or approved to produce a 
finished dosage form (FDF) of a human generic drug or an active 
pharmaceutical ingredient (API) contained in a human generic drug. 
Thus, facilities engaged in manufacturing or processing a generic API 
or FDF must be identified. For purposes of self-identification and 
payment of fees, GDUFA defines API and FDF manufacturers differently 
from the way they have been defined historically. The GDUFA definitions 
are included in the draft guidance for industry entitled ``Self-
Identification of Generic Drug Facilities, Sites and Organizations,'' 
available at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
    2. Sites and organizations that package the FDF of a human generic 
drug into the primary container/closure system and label the primary 
container/closure system. Sites and organizations that package the FDF 
of a human generic drug into the primary container/closure system and 
label the primary

[[Page 60126]]

container/closure system are considered to be manufacturers, whether or 
not that packaging is done pursuant to a contract or by the applicant 
itself.
    3. Sites that are identified in a generic drug submission and 
pursuant to a contract with the applicant remove the drug from a 
primary container/closure system and subdivide the contents into a 
different primary container/closure system (contract repackagers).
    4. Bioequivalence (BE)/bioavailability (BA) sites that are 
identified in a generic drug submission and conduct clinical BE/BA 
testing (i.e., clinical research organizations), bioanalytical testing 
of samples collected from clinical BE/BA testing, and/or in vitro BE 
testing.
    5. Sites that are identified in a generic drug submission and 
perform testing of one or more attributes or characteristics of the FDF 
or the API pursuant to a contract with the applicant to satisfy a 
current good manufacturing practice testing requirement (excluding 
sites that are testing for research purposes only).

II. What type of information must be submitted?

    The information required to be submitted is identified in GDUFA SPL 
Industry Technical Specification Information document available at 
www.fda.gov/gdufa. Note that the name and contact information for both 
the registrant owner and the facility, if they are different, must be 
submitted. This information includes the type of business operation, 
and, if applicable, the Data Universal Numbering System (DUNS) 
number(s) and the Facility Establishment Identifier (FEI). A DUNS 
number is a unique nine-digit sequence provided by Dun & Bradstreet, 
Inc. An FEI is a unique identifier designated by FDA to assign, 
monitor, and track inspections of regulated firms. Business entities 
will also be asked if they manufacture drugs other than generics.
    A facility or site that has previously registered with FDA (under 
section 510 of the Federal Food, Drug, and Cosmetic Act or section 351 
of the Public Health Service Act), can verify its DUNS number(s) and 
FEI(s) on FDA's registration site for drug establishments available at 
http://www.accessdata.fda.gov/scripts/cder/drls/default.cfm. 
Information on obtaining a DUNS number or FEI(s) is provided in the 
draft guidance for industry entitled ``Self-Identification of Generic 
Drug Facilities, Sites and Organizations,'' available at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. FDA encourages business entities to obtain the necessary 
information as soon as possible to avoid delay.

III. What is the means and format for submission?

    The new electronic self-identification process will be familiar to 
many business entities who have previously submitted information to FDA 
electronically. Self-identification files should be formatted in the 
same electronic messaging standard used for drug registration and 
listing information and for the content of labeling for abbreviated new 
drug applications (ANDAs). This standard known as Health Level Seven 
SPL allows information to be exchanged, searched, and combined with 
other data sources in a manner that supports health information 
technology initiatives to improve patient care.
    The required information may be submitted using any of the 
following tools to generate a self-identification SPL file:
    1. eSubmitter tool, a free stand-alone application available at 
http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm108165.htm. Step-by-
step instructions for electronically creating, validating, and 
submitting self-identification information through eSubmitter are 
available in ``eSubmitter Quick Guide--Generic Drug Facility Self-
Identification'' available at http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm274477.htm; or
    2. Xforms, a free tool for generating SPL files available at http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm189651.htm. Step-by-step instructions for electronically creating, 
validating, and submitting self-identification information using Xforms 
are available at http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm; or
    3. Software tools developed internally by generic manufacturers 
utilizing the SPL technical specifications. Additional information is 
available at http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm.
    4. Other commercially available applications (e.g., vendor tools).
    Once a self-identification SPL file is created and finalized, 
transmit the file to FDA through the ESG, FDA's electronic information 
portal. More information on ESG procedures and process is available on 
the Electronic Submission Gateway Web site (http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm).

IV. What is the penalty for failing to self-identify?

    Under GDUFA, if a facility fails to self-identify, all FDF or API 
products manufactured at the facility and all FDFs containing APIs 
manufactured at the facility will be deemed misbranded. It is a 
violation of Federal law to ship misbranded products in interstate 
commerce or to import them into the United States. Such a violation can 
result in prosecution of those responsible, injunctions, or seizures of 
the misbranded products. Products that are deemed misbranded because of 
failure of the facility to self-identify are subject to being denied 
entry into the United States.

    Dated: September 28, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-24326 Filed 10-1-12; 8:45 am]
BILLING CODE 4160-01-P